BEUDAMED
    FDA Adverse Event Other Summary report: N

    RXSTAGE SYSTEM ONE

    MDR report key: 608204 · Received May 27, 2005

    Report

    Report Number
    3003464075-2005-00015
    Event Type
    Other
    Date Received
    May 27, 2005
    Date of Event
    April 7, 2005
    Report Date
    April 27, 2005
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT, A PATIENT BLOOD LOSS OF APPROXIMATELY 100 CC OCCURRED. THIS EVENT WAS NOT ASSOCIATED WITH A DEVICE MALFUNCTION OR SERIOUS INJURY AND IS BEING REPORTED SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS POLICY. IT WAS REPORTED THAT AFTER COMPLETION OF THE PATIENT'S TREATMENT, FREQUENT VENOUS PRESSURE HIGH ALARMS OCCURRED WHILE PERFORMING RINSEBACK. THE ALARMS COULD NOT BE RESOLVED. ONLY HALF OF THE BLOOD WAS RETURNED WHEN IT WAS DETERMINED THAT THE BLOOD CIRCUIT WAS CLOTTED PRECLUDING RINSEBACK OF THE REMIANDER OF THE BLOOD. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR - 153 PG-050329-01

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other